Cellectis (ALCLS) Q4 2025 earnings summary

Executive summary

• Achieved 100% overall response rate in the target Phase 2 population for lasme-cel in r/r B-ALL, with all patients becoming transplant-eligible and strong interim Phase 1 results for eti-cel in r/r NHL (88% ORR, 63% CR), mostly in heavily pretreated patients.

• Initiated pivotal Phase 2 trial for lasme-cel in B-ALL, enrolling across North America and Europe, with interim analysis of 40 patients expected in Q4 2026.

• Strategic partnerships with AstraZeneca, Servier, Allogene, and Iovance progressing, with key data readouts and milestones anticipated in 2026 and beyond.

• Arbitration with Servier resulted in partial license termination for UCART19 V1, but milestone eligibility for Cema-cel remains unaffected and direct licensing discussions possible.

• Cash and equivalents of $211 million as of December 31, 2025, expected to fund operations into H2 2027.

Financial highlights

• Revenues and other income rose to $79.6 million for 2025, up from $49.2 million in 2024, mainly due to AstraZeneca collaboration.

• R&D expenses increased to $93.5 million from $90.5 million year-over-year; SG&A expenses rose to $19.8 million from $19.1 million.

• Net financial loss of $34.9 million in 2025, compared to a net financial gain of $22.8 million in 2024, due to lower financial income and higher expenses.

• Net loss attributable to shareholders was $67.6 million ($0.67/share) in 2025, versus $36.8 million ($0.41/share) in 2024; adjusted net loss was $61.5 million ($0.61/share).

• Major cash outflows included $50.5 million to suppliers, $40 million in wages and social expenses, $11 million in lease debt payments, $5.4 million loan repayment, and $3.5 million in capital expenditures.

Outlook and guidance

• Pivotal Phase 2 interim analysis for lasme-cel in r/r B-ALL expected in Q4 2026; BLA submission anticipated in H2 2028.

• Eti-cel expected to progress to pivotal Phase 2 in 2027, with full Phase 1 dataset including IL-2 cohort expected in Q4 2026 and BLA submission planned for H2 2029.

• Cash runway projected into H2 2027, supporting ongoing clinical and manufacturing activities.

• Key partnered program readouts expected: Servier/Allogene Cema-cel in April 2026, Iovance IOV-4001 in 2026.